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Korea reviewing emergency approval for Merck’s COVID-19 pills

Data on Celltrion COVID-19 drug’s effectiveness against delta not available yet

Minister of Food and Drug Safety Kim Ganglip speaks to reporters during a press conference held Wednesday at the ministry headquarters in Osong, North Chungcheong Province. (Ministry of Food and Drug Safety)
Minister of Food and Drug Safety Kim Ganglip speaks to reporters during a press conference held Wednesday at the ministry headquarters in Osong, North Chungcheong Province. (Ministry of Food and Drug Safety)
The Ministry of Food and Drug Safety is looking at data on the COVID-19 antiviral pill from Merck for emergency use approval, the result of which, he said, is anticipated to be out sometime next month, Kim Gang-lip, who heads the ministry said Wednesday.

Merck is one of two companies that Korea has entered an advance purchase deal with for their oral medicines, the other being Pfizer. Pfizer, as of Wednesday, has yet to submit an emergency approval application.

Kim said the ministry was aiming to complete the approval process for Novavax’s COVID-19 vaccine before the year is over. Novavax, which has a deal to provide Korea with enough vaccines for 20 million people, applied for approval here Monday.

He said the ministry would be “monitoring how the regulatory reviews are proceeding in other countries,” but that wouldn’t impact the decisions being made here.

On European drug authorities’ recent endorsement of Celltrion’s antibody therapy against COVID-19 Kim said that the development is “meaningful,” but said data on its effectiveness against the delta variant was not yet available.

The European Union’s drug regulator backing approval of the COVID-19 antibody treatment from Celltrion last week was “a meaningful development,” the minister said. In a Nov. 11 statement, the European Medicines Agency recommended the Korean drugmaker’s Regkirona for use in adults not requiring oxygen support and at high risk of severe disease.

“It took us (the Korean drug ministry) 40 days to greenlight Celltrion’s Regkirona, while it had taken the European Medicines Agency nine months,” he said. Kim said that many of the ministry officials were “anxiously awaiting” the EMA’s verdict.

He said that “a decision from the EMA that does not align with ours would have subjected our regulatory capacity to scrutiny.”

“Forty days of review by the ministry had shown to be just as thorough as the nine months that had taken the EMA,” he said, adding that he was proud of the nod from an international regulatory authority.

In response to The Korea Herald’s question asking how well Celltrion’s antibody treatment was performing after delta became the dominant strain in Korea, he said that data was “still coming.”

“The real world data on how Regkirona is faring against delta is expected to become available before the end of this year,” he said. Jointly with the National Institute of Health, the Korea Disease Control and Prevention Agency and Celltrion, the ministry was studying and analyzing the antibody treatment effectiveness against delta.

Since gaining conditional approval from the Drug Ministry in February, the treatment -- based on monoclonal antibodies that act like natural antibodies to fight infections -- from Celltrion was administered to 20,225 patients here as of Oct. 27.

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